| Tablets having an emulsified polymer matrix for the controlled emission of gas, and production process -> Monitor Keywords |
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  Tablets having an emulsified polymer matrix for the controlled emission of gas, and production processRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Biocides; Animal Or Insect Repellents Or Attractants (e.g., Disinfectants, Pesticides, Etc.)The Patent Description & Claims data below is from USPTO Patent Application 20070092543. Brief Patent Description - Full Patent Description - Patent Application Claims
OBJECT OF THE INVENTION [0001] The invention relates to tablets capable of producing gases in a controlled manner for their preferred use in apparatuses intended for the administration of medicaments, blood and derivatives, or serums, such that the gas exerts the primary control of the rate of release of the serum or medicament to the patient. The tablets are found in a matrix which allows the reaction between an acid and a base (or an enzyme substrate and an enzyme), appropriately chosen, to take place in a controlled manner, particularly with a constant gas evolution rate during the useful life of use of the tablet. [0002] The invention relates to medical devices for administering substances to the patient as well as to techniques for the controlled emission of gases for their use at home or as fumigants. STATE OF THE ART [0003] It is necessary for hospital purposes to obtain a method of continuous release of medicaments or serum or the like for their continuous (normally intravenous) injection in the patient. Devices allowing such use are known, but they usually require additional devices (for example metallic structures) that allow the fall by gravity of the solution to be injected. A way of improving and reducing the cost and number of devices necessary for a continuous injection of medicaments is to eliminate the need to place the drip above the injection site. This allows to be able to administer the necessary medicaments, blood, etc. to the patient in extreme situations (e.g. in car accidents) where it is not feasible to place the drip, which operates by gravity, above the patient. The use for the same purpose of peristaltic pumps which rely on a generally electric power supply is also known. [0004] The technique of exerting pressure by means of the presence of a gas in a receptacle wherein the solution to be injected is located is known. As a non-limiting example, the solution to be injected may be found in a flexible (plastic) bag which is compressed with the presence of the gas or, according to another non-limiting example, the solution is found in a infusion device with a plunger, which is displaced by the presence of the gas, thus imitating a manual injection with a needle/plunger. [0005] Many of these devices which use the presence of a gas as a way of controlling the injection rate of solutions to the patients are based on electrolytic methods where the presence of an electric current causes a reaction in which the gas is produced and carried to a receptacle wherein the solution to be injected is packaged in a plastic film. These devices may be electronically adjusted by regulating the voltage so as to produce a greater or smaller gas evolution. The great drawback of these devices is their high cost and the reliance on a electricity source, and in the particular case of running on batteries, the exhaustion thereof causes a sudden stop of the injection process both in the electrolytic mechanisms and peristaltic pumps, apart from a high cost of the building materials of said drips. [0006] The use of tablets consisting of sodium bicarbonate or sodium carbonate, which upon being combined with an acid --at the time the medical personnel wants to start the injection--(for example by rupture of a plastic film separating the acid from the basic tablet --the reaction thus starting--) cause the emission --by chemical reaction--of CO.sub.2, is known. Other gas generating chemical reactions are possible (nitric oxide, nitrous oxide, hydrogen, etc.) but some are not convenient since either the generated gases are not adequate due to their toxicity or inflammability or the compounds that generate them are expensive. [0007] On the other hand, traditional methods of disinfection or fumigation of soils intended for agricultural crops (also applicable e.g. to fumigation in industrial premises) make use of lethal gases which require great control in their handling. A typical example in the pre-planting disinfection and fumigation of agricultural soils is the use of hydrogen cyanide or methyl bromide. The present invention shows a much safer method of applying these extremely toxic compounds thanks to the emission control of the tablets and their "low toxicity" form before their use (the reactive components are enclosed in the tablet, preferably with emetics, and provide a reduced toxicity by virtue of their enclosure in the tablet --the ingestion of which is prevented by emetics--before a solution causes the start of the toxic gas generating reactions). [0008] All said tablets currently in the market as well as those described in patent (e.g. FR 27845832, EP 0669129, FR 2762213, WO 9811879) or scientific literature suffer from a pronounced gas evolution at the start of the chemical reaction between the acid and the base, the quantity of generated gas decreasing exponentially or at best linearly with a steep slope. [0009] The present invention constitutes a marked improvement regarding the state of the art as far as the applicant has developed basic (or acid, or containing the acid and base in the same tablet) pills which upon reaction with an acid (or base, or tablet disintegrant) --or acid and basic at the same time--cause a constant gas evolution; in chemical terms it could be said the gas forming reaction is of an order of 0, and its emission goes on for a considerable time in comparison with the state of the art. DETAILED DESCRIPTION OF THE INVENTION [0010] Due to economic and toxicological reasons, the inventors have chosen as a preferred embodiment mode [only for a description of the invention in a practical manner] basic tablets (due to the presence of sodium carbonate) and a non-toxic acid such as citric acid. The following description avails itself of this non-liming example whatsoever such that the invention is understood in a practical and simple manner and is capable of being carried out by person skilled in the art. [0011] The effervescent tablets are made such that the access of citric acid to sodium carbonate takes place in a controlled manner. Up until now, the only control described and known at least by the authors, the contact between acid and base, takes place without any type of physical or chemical protection, except for the use of films which separate the acid solution from the basic tablet. These described membranes are not capable of regulating the flow of acid inside the receptacle wherein the basic tablets are, or alternatively, the flow of alkali which comes in contact with acid tablets, or alternatively, the flow of water that dissolves the pills containing the acid and base, such that, because of a greater contact surface at the start of the reaction or of a greater accessibility for the bonding of acid and base, a large gas evolution takes place at the beginning of the process. This gas evolution in commercial tablets studied by the inventors takes place in an uncontrolled manner, and in those described tablets (e.g. FR 27845832, EP 0669129, FR 2762213, WO 9811879) in which a hydrophilic polymer exerts the control of the reaction by means of channels that make way for water, these channels are rapidly destroyed by the "explosions" of water bubbles (CO.sub.2). It is true that initially a control is indeed exerted by means of said inventions, but in no event whatsoever, according to the experiments carried out by the authors following the instructions present in said documents, may a regular control of the emission of CO.sub.2 be achieved for more than 1 hour (for a tablet size and an emitted CO.sub.2 quantity appropriate for exerting sufficient pressure for the actuation of the injection mechanism). It is to be noted that in none of said patents the use of these pills is described for causing CO.sub.2 pressure; the use of those patents is intended for effervescence and is of permanence in the stomach. This time factor, then, is crucial thanks to the novel inclusion of a oil phase in this type of tablets, furthermore in the form of an emulsion integrated in a polymer matrix of a hydrophilic nature. In no event the combination of an emulsion with a hydrophilic polymer belongs to the state of the art. Furthermore, the existence of oil in the tablet no only exerts a fundamental effect on the diffusion of the liquid that the reaction produces (either alkaline, basic, neutral or even an enzyme solution, as will be seen below), but exerts a physical barrier against microexplosions of the formed gas, protecting the tablet structure (matrix) that controls the reaction. Moreover, the existence of the emulsion allows the inclusion of materials of a liquid nature in the tablets (e.g. a water-in-oil emulsion, the water containing enzymes that catalyze gas generating reactions). [0012] The inventors present a way of controlling the physical contact of the base (or acid) with the acid (or base) by means of an innovative method of encapsulating the basic or acid tablet by means of an emulsion that regulates the diffusion of the acid or base or neutral compound in the tablet, this emulsion being of a polymeric nature. There are basically three combinations so that acid-base reaction takes place and three so that an enzymatic reaction occurs: [0013] Alkaline Tablet--Acid Solution [0014] Acid Tablet--Alkaline Solution [0015] Alkaline+Acid Tablet--Neutral Solution [0016] Enzymatic Tablet--Solution with Anabolite [0017] Tablet with Anabolite--Enzymatic Solution [0018] Tablet with Anabolite+Enzymes--Tablet Disintegrating/Solubilizing Solution [0019] In a preferred embodiment mode of the invention, the effervescent tablets are made by means of the mixture of sodium carbonate in an emulsioned matrix of an oil in an ethylene glycol-type polymer. The emulsion is carried out with the aid of a dispersant (a polymer dispersant in a petroleum fraction with a high boiling point) and a sorbitan-type emulsifier, chosen in a non-limiting manner. Akofine R.RTM. (Karlshamms) and Atlox LP6.RTM. (Uniquema) are additives used in the present embodiment in an illustrative and non-limiting manner. [0020] In a first step, the emulsion constituents are mixed and heated to an appropriate temperature that allows their fusion (preferably ranging from 50 to 100.degree. C.) in the presence of agitation with a polytron. Once the emulsion has an homogenous appearance, sodium carbonate is added to the emulsion. The sodium carbonate is granulated in very fine particles and must be perfectly homogenized regarding granule size. It is a factor of extreme importance since the size of the sodium carbonate granule will subsequently have a decisive influence on the production of CO.sub.2 and its diffusion. The sodium carbonate is at the same temperature that the emulsion has, although it might be convenient to raise the temperature of the mixture of the emulsion (which consists of said hydroxylated polymers --which act as "aqueous" phase"--of a dispersant and the oil). Next, mixing, in an intense manner, of all of the components (sodium carbonate with the emulsion) is initiated such that obtaining a solid dispersion with the emulsion homogenously adsorbed in the sodium carbonate surface (or any other solid in other preferred embodiments) is ensured. Once the mixture is considered homogenized, the semisolid paste, to a greater or smaller degree of viscosity, is poured into molds which, after pressing and cooling, give raise to the tablets of sodium carbonate embedded in an emulsified polymer matrix. The composition by weight of the described tablet is sodium carbonate (48%)/ethylene glycol 4000 (25%)/Akofine.RTM.(25%)/Atlox LP6.RTM.(1%)/Span 65(1%). [0021] The inventors have discovered that in order to obtain this type of emulsion with great ease (not excluding other ways of carrying out the process), the fusion temperature of the components of the oil-hydrophilic polymer tablet must be similar, although this is not necessary. Continue reading... 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